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NOT YET RECRUITING
NCT07300033
PHASE1

Bioequivalence Study of Liquid Metformin (100 and 250 mg/mL) vs IR Tablets

Sponsor: Aspargo Labs, Inc

View on ClinicalTrials.gov

Summary

This is an open-label, randomized, two-treatment, two-period crossover study evaluating the bioequivalence of liquid metformin formulations at 100 mg/mL and 250 mg/mL compared with immediate-release metformin tablets in healthy adult subjects. Each participant will receive both treatments in randomized sequence with an adequate washout interval between periods. Serial blood samples will be collected to assess metformin pharmacokinetics, and safety will be monitored throughout the study.

Official title: Bioequivalence of Liquid Metformin (100 mg/mL and 250 mg/mL) and Immediate-Release Metformin Tablets: A Randomized, Crossover Study in Adult Subjects

Key Details

Gender

All

Age Range

18 Years - 55 Years

Study Type

INTERVENTIONAL

Enrollment

24

Start Date

2026-05-15

Completion Date

2026-07-28

Last Updated

2025-12-23

Healthy Volunteers

Yes

Interventions

DRUG

Liquid Metformin 100 mg/mL

A single oral dose of a liquid metformin formulation at a concentration of 100 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

DRUG

Liquid Metformin 250 mg/mL

A single oral dose of a liquid metformin formulation at a concentration of 250 mg/mL will be administered under fasting conditions in one treatment period of the crossover.

DRUG

Metformin Immediate-Release Tablet

A single oral dose of standard immediate-release metformin tablet(s) will be administered under fasting conditions in one treatment period of the crossover.